Principal Regulatory Writer, Global Rare Diseases

About usChiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.Chiesi Global Rare DiseasesChiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available.This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here.What we are looking forThis is what you will doWithin the Global Rare Diseases, R&D, Regulatory Affairs and reporting to the VP, Global Regulatory Affairs, Global Rare Diseases the Principal Regulatory Writer is responsible for authoring, reviewing, and managing regulatory documents that translate clinical, nonclinical and CMC data into clear, accurate, and compliant submissions for global health authorities (e.g., FDA, EMA, MHRA, NMPA, Health Canada), supporting both initial marketing applications and post‑approval lifecycle activities for drugs and biological products.They serve as a central member of cross‑functional regulatory submission teams, working in close collaboration with Global and Regional Regulatory Leads, Clinical Development, Biostatistics, Safety/Pharmacovigilance, CMC, Medical Affairs, and external partners to ensure consistency, scientific rigor, and regulatory alignment.They are accountable for document development across the full product lifecycle, including original applications, variations/supplements, responses to regulatory questions, periodic updates, other post-approval life cycle management documents.They provides coordination, oversight, and guidance for regulatory writing activities across Global Rare Disease (GRD) development programs, ensuring harmonization of messaging and adherence to global standards.You will be responsible forOversee the drafting, review, and finalization of key regulatory and clinical documents, including but not limited to:CTD Module 1 and 2 documents, including:1.6.1 and 1.6.2 (Meeting requests and packages) .2.4, 2.5, 2.7.3, 2.7.4, 2.7.5, 2.7.6 etc. (e.g. Nonclinical and Clinical summaries and overviews)Addenda, updates, consolidation, alignment of Module 2 documents required to support post‑approval variations, extensions, or annual benefit–risk reassessmentsRegulatory response documents, including responses to Questions, Information Requests, Requests for Information (RFIs), Major Objections, Clarifaxes, and List of Outstanding IssuesDocuments of required for clinical development and post-approval life cycle management, including clinical study protocols, clinical study reports, investigator’s brochures,Expedited and Special Program applications (e.g. Orphan Designation Requests, Rare Pediatric Disease Designation Requests, RMAT, Breakthrough, Fast Track, PRIME, Sakigake, Priority Review Voucher RequestsEnsure all regulatory documents are fully compliant with eCTD specifications and applicable regional and international guidelines (e.g., ICH, FDA, EMA).In collaboration with Global Regulatory Leads and Regional Regulatory Leads, support timely and high‑quality dossier assembly and submission, managing document timelines and cross‑functional inputs.Maintain awareness of current and evolving global regulatory requirements, proactively incorporating regulatory intelligence into authored submissions.Provide subject-matter expertise and leadership in the development, maintenance, and implementation of role‑relevant tools, SOPs, work instructions, templates, and style guides.Coordinate and manage external regulatory writers and internal subject matter experts, ensuring quality, consistency, and adherence to agreed timelines for marketing authorization and lifecycle submissions.Train and guide cross‑functional contributors on best practices for regulatory writing, including adherence with Chiesi standards and styles, document structure, data presentation, traceability, and version control.Contribute to resource planning, ensuring adequate FTE and budget support to meet program and organizational regulatory writing needs.You will need to haveRelevant life science university degree, PhD or Pharm. D in Biochemistry, Pharmacology, or a related field. RAC PreferredDemonstrated experience authoring and/or leading the development of regulatory documents across the drug development lifecycle, such as: Health Authority Meeting Requests, Packages, Briefing Documents; Critical / Key Module 1 documents; Nonclinical and Clinical Overviews and Summaries (CTD Module 2); Response documents to regulatory authorities; Expedited and Special Program Requests and Designation Packages (e.g. Orphan Drug Designation Requests, Fast Track, Prime, RMAT, Breakthrough, Sakigaki, etc.); Clinical Trial Applications/Dossiers (e.g., IND, CTA, NDA/BLA modules)Background knowledge in rare diseases is highly desirableFluent in both the written word and spoken EnglishTechnical SkillsStrong familiarity with global regulatory frameworks and expectations, including FDA and EMA requirementsAdvanced knowledge of ICH guidelines governing regulatory document structure, format, and content, including but not limited to ICH E3, E6, E9, and M4Strong understanding of the end to end drug development process, regulatory strategy considerations, and the informational needs of internal and external stakeholdersProficient in interpreting complex clinical and statistical data, with the ability to present results clearly, convincingly, and concisely in a regulatory contextAdvanced proficiency in MS Office applications (Word, PowerPoint, Excel, Teams) and Adobe Acrobat, including document formatting, review, and alignment with eCTD requirements to facilitate efficiency in the publishing of regulatory submissionsSoft SkillsExceptional written and verbal communication skills, with the ability to convey complex scientific and regulatory concepts clearly to both technical and non technical audiencesHighly organized and proactive, with the ability to manage multiple deliverables under tight timelines while maintaining high standards for quality and complianceExcellent attention to detail, including data consistency, traceability, and alignment across submission documentsProven ability to build, guide, and maintain cohesive and collaborative teams, including mentoring junior writers and contributors (candidates with leadership development aspirations will be considered)Strong motivation, coordination, and conflict resolution skills within a matrixed, cross functional environmentExcellent problem solving skills and the ability to work both independently and collaboratively in multidisciplinary teamsCompensation Range (Package for role based in Italy)The minimum salary for this role is 59.040, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme.The package outlined above is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process. LocationThe role can be based in the HQ in Parma or in one of Chiesi affiliates in EuropeWhat we offerNo matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.